Small biotechs raise millions; FDA approves MedImmune's H1N1 vaccine

A handful of small Maryland bioscience companies have raised millions of dollars in recent weeks, but for some the investment community's response has been lukewarm.

For example, Arginetix of Lutherville has so far raised $4.2 million in a $17.5 million offering, according to its filing with the Securities and Exchange Commission. Arginetix, founded in 2007, focuses on developing and commercializing arginase inhibitors for treating cardiovascular, respiratory and other diseases. Arginase is an enzyme that works in liver functions; elevated levels contribute to vascular eye disease.

Innovative Biosensors in Rockville, which develops and makes rapid pathogen-detection systems, has raised $1.75 million of a $2.57 million offering, according to its SEC filing.

Gliknik has raised $2.89 million of its $3.61 million offering. The Baltimore company is developing treatments for cancer and autoimmune and inflammatory diseases.

Gaithersburg biotech MaxCyte has raised $1.12 million of its $1.25 million offering. The company provides cell modification technology to the life sciences industry. And Towson startup LeukoDx, which is developing diagnostic systems based on NASA technology, raised $377,000 of a $1 million offering.

Meanwhile, other small companies have raised their millions in other ways.

BioMarker Strategies reported raising $1.7 million in a private placement round that took advantage of the state's biotech investment tax credit program. The Baltimore company is developing a test to help oncologists determine the most effective drug treatment for their cancer patients. The largest investment came from the Abell Foundation, a Baltimore nonprofit.

"We are honored to have the Abell Foundation as our first institutional investor. We also welcome their support of our effort to develop a live tumor cell testing system designed to help oncologists choose the right drug therapy for their cancer patients," CEO K‰ren Olson said in a statement. "Even in this challenging economic environment, we found that investors are eager to support innovative biotech companies."

And Sanaria, the Rockville biotech that's developing malaria vaccines, reported winning a $1.99 million, two-year Small Business Innovation Research grant from the National Institutes of Health. The company plans to use the phase 2 grant to increase the efficiency of the manufacturing and other processes required for phase 3 clinical testing of its vaccine.

Pending satisfactory progress, the company stands to receive an additional $1 million in a third year of funding. Since 2003, Sanaria has received more than $17 million in such NIH grants.

In other Maryland bioscience industry news:

MedImmune and Novavax both had positive news on the flu vaccine front.

AstraZeneca's MedImmune in Gaithersburg was one of four companies whose H1N1 flu vaccines were approved last week by the Food and Drug Administration. Supplies are expected next month, the FDA said in a statement.

MedImmune, like the other manufacturers, has used the conventional chicken egg method of growing the virus, but its vaccine uses a live, rather than killed, virus strain and is administered via nasal spray, not injection. All the approved vaccines "induce a robust immune response in most healthy adults eight to 10 days after a single dose, as occurs with the seasonal influenza vaccine," the FDA said.

The most common side effects from the MedImmune vaccine are runny nose or nasal congestion for all ages, sore throats in adults and fever in children 2 to 6, according to the FDA.

Novavax, next door in Rockville, reported positive results from a phase 2 human clinical trial of its trivalent seasonal influenza virus-like particle vaccine candidate. The vaccine was well tolerated and induced robust immune responses against all three flu strains in the vaccine, the company said.

This fall, the company plans to start testing the vaccine directly against conventional egg-based vaccines in elderly patients. Those results and the new data may support moving the vaccine into phase 3 trials next year, Novavax said.

The company touts its virus-like particle technology as superior to conventional vaccines, as it produces genetic matches to the targeted flu strains, resulting in a safer, more effective and more quickly produced vaccine.

The new results also support the company's efforts in developing an H1N1 vaccine, said CEO and president Rahul Singhvi in a statement.

Novavax also said it has contracted William Smith & Co. as an agent to sell $10 million of common stock.

Edward M. Rudnic, chairman of the Tech Council of Maryland, and founder and former chairman and CEO of Middlebrook Pharmaceuticals of Germantown, who has been planning his next entrepreneurial move, has made it.

He has launched UnionBridge Management, with co-founder H.K. "Duke" Baboyian, longtime entrepreneur and businessman, at an office in Potomac. UnionBridge will provide investment, development and marketing expertise to pharmaceutical research organizations and universities, and provide advisory services for inventors and intellectual property owners.

The latest chapter in the battle between anthrax vaccine-maker Emergent BioSolutions of Rockville and its one-time acquisition target, Protein Sciences Corp. of Meriden, Conn., unfolded in a federal bankruptcy court in Delaware last week when a judge rejected Emergent's involuntary Chapter 7 petition against Protein Sciences, which was filed in June.